MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vticm5_13.2, -9.5/1.5/1100 (sphere/cylinder/axis), implantable collamer lens tore during injection/delivery into the patient's right eye (od) on (b)(6) 2023.There was patient contact (lens touched the eye) with no patient injury.The lens was replaced intraoperatively with the back up lens.This resolved the problem.Cause of the event is reported as other: lens quality (yellowing found around edges of lens).
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial, in liquid.Visual inspection found the lens haptic torn and it was noted lens was observed in different lighting/setting under the microscope and yellow was not noted aroudn the edges.H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim#: (b)(4).
Additional Manufacturer Narrative
Correction: b5 - -9.5/1.5/110 (sphere/cylinder/axis).Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17948874
• Report Number: 2023826-2023-04431
• Device Sequence Number: 18097969
• Product Code: QCB
• UDI-Device Identifier: 00841542116510
• UDI-Public: 00841542116510
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 02/07/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 02/07/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45,LOT#1626236.; FOAMTIPPLUNGER MODEL#FTP,LOT#1643206.; INJECTOR MODEL#LIOLI-24,LOT#FC14401.
• Patient Age: 32 YR
• Patient Sex: Male